Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- CG Anxiety at 20 Weeks Post-treatment
研究概览
简要总结
The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.
详细描述
This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment.
The objectives of this study are to:
- Evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, HRQOL, and fatigue) outcomes.
- Measure the effect of the intervention, as compared to a control group, on patient outcomes (HRQOL and interrupted treatment course), and healthcare utilization outcomes (unplanned hospital admissions, unplanned emergency room visits, and unplanned use of intravenous [IV] fluids).
- Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety.
- Determine if patient illness factors, care demands (hours per week spent caregiving), and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes.
- Compare the costs of healthcare utilization (unplanned hospital admission, unplanned emergency room visits, and unplanned use of IV fluids) between the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Research Assistant (RA) will be blind to which group CG is assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(for patients):
- •18 years of age or older.
- •Diagnosis of stage I, II, III cancers of the rectum and anus, stage I, II, III, IVa esophagus; stage II-III NSCLC (excluding those receiving SBRT due to short treatment course); and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). Stage IV A/B will be allowed for HNC and stage IVa for esophagus as the intent of therapy is curative.
- •Has an identified family CG who is willing to participate.
- •Inclusion Criteria (for CGs):
- •18 years of age or older
- •Family member or friend of an adult patient described above
- •Identified by the patient as his/her primary CG, who is providing daily assistance and/or emotional support.
排除标准
- •Patients who do not have a caregiver will be excluded.
- •CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care.
- •CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).
研究组 & 干预措施
Control - Standard of Care
CG(caregivers)/CP(cancer patients) dyads
Intervention
CG/CP dyads
- Three, one-on-one support/educational sessions with the caregiver during radiation treatment, followed by a telephone booster contact 2 weeks post-treatment.
干预措施: One-on-one support/educational sessions (Behavioral)
Intervention
CG/CP dyads
- Three, one-on-one support/educational sessions with the caregiver during radiation treatment, followed by a telephone booster contact 2 weeks post-treatment.
干预措施: Telephone booster contact (Behavioral)
结局指标
主要结局
CG Anxiety at 20 Weeks Post-treatment
时间窗: 20 weeks post treatment
Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment. CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
次要结局
- CG Anxiety at Baseline(Baseline)
- CG Anxiety at the End of Radiation Treatment(At end of treatment, average of seven weeks)
- CG Anxiety at 4 Weeks Post Treatment(4 weeks post treatment)
- CG Depression(at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment)
- CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain(at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment)
- CG HRQOL as Measured by PROMIS Global Health Scale - Global Physical Health(Baseline, end of treatment, 4 weeks and 20 weeks post treatment)
- CG Fatigue(at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment)
- Participant HRQOL (Cancer Patient) as Measured by FACT-G(at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment)
- Interrupted Treatment(End of radiation treatment, average of seven weeks)
- Healthcare Utilization for Participants, as Measured by Number of Hospital Admissions(20 weeks post treatment)
- Healthcare Utilization for Participants, as Measured by Number of Emergency Room Visits(20 weeks post treatment)
- Healthcare Utilization for Participants, as Measured by Number of Visits for IV Hydration(20 weeks post treatment)